A Truvada lawsuit is a mass tort claim against the pharmaceutical company Gilead Sciences, Inc. for the side effects of Truvada, a pill that helps to treat and prevent HIV and AIDS. Truvada has been linked to serious side effects such as kidney damage and failure, as well as osteoporosis, a decrease in bone density, and broken bones. The lawsuits claim that, not only did Gilead fail to warn patients about these risks by not disclosing them, but they even withheld a safer drug for a decade in order to maximize their profits.
In this article, our defective drug lawyers will look at the drug Truvada (and the broader TDF category) and the health risks it can create. We will then turn to the failure to warn lawsuits that have been filed against Gilead for the side effects of Truvada, including the evidence that Gilead withheld a safer drug to boost its profits. Finally, we will explain the types of compensation you can recover if you file a lawsuit, and what you can do if you have suffered from Truvada.
- 1. What is Truvada?
- 2. The health risks associated with Truvada
- 3. Lawsuits over Truvada's side effects
- 4. Compensation available for victims of Truvada
- 5. What you can do if you have been hurt
- 6. Contact our defective drug lawyers
1. What is Truvada?
Truvada is a drug that was designed to treat and prevent human immunodeficiency virus, or HIV, and acquired immune deficiency syndrome, or AIDS. As a combination of the chemicals emtricitabine and tenofovir disoproxil fumarate (TDF), Truvada keeps HIV cells from multiplying once in the body.
Importantly, this means that Truvada does not cure HIV or AIDS. Instead, it merely contains HIV and keeps it from developing into AIDS. This stops short of actually eliminating HIV from a patient's system.
Truvada, however, can also be used as a prophylactic drug to prevent HIV contraction. Many people who do not have HIV or AIDS, like those in an intimate relationship with someone who is HIV-positive, can take Truvada to reduce the risk of becoming infected.
One of the drugs in Truvada, TDF, has been around since the 1980s. However, its use for HIV had been limited because it could only be taken intravenously. When Gilead Sciences, Inc. bought the rights to sell TDF, though, they modified it so it could be taken orally, in the form of a pill. That oral medication was approved by the U.S. Food and Drug Administration (FDA) in 2001 under the brand name Viread.1
Since approval, TDF has been sold under a handful of other names, including:
Some of these medications combine TDF with other HIV/AIDS drugs. For example, Truvada combines TDF with emtricitabine, a chemical that reduces the ability of HIV RNA cells to turn into HIV DNA, preventing them from becoming viral. Truvada was approved by the FDA in 2004.2
2. The health risks associated with Truvada
Truvada, however, has been linked to numerous side effects. Some are much more severe than others.
Common but less severe side effects include:
- Abdominal and stomach pain,
- Decreased weight,
- Liver problems,
- Sleeping problems, including vivid dreams,
- Fatigue or weakness,
- Muscle pain,
- Difficulty breathing, and
- Skin rash.
There are also several much more severe side effects that have been linked to Truvada, though:
- Decreased bone density and osteoporosis,3
- Kidney damage and renal failure,4 and
- Lactic acidosis.5
2.1. Decreased bone density and osteoporosis
One of the serious side effects of Truvada is a decrease in bone density. This can lead to the medical condition osteoporosis. These problems are caused by the high dosage levels of Truvada, the toxicity of which slowly deteriorates a patient's bone structure.
Because Truvada is not a cure for HIV or AIDS, but is rather a treatment for the conditions, it is intended to be taken for prolonged periods of time. This long-term exposure to Truvada and the drug TDF takes a significant toll on a patient's bone density, drastically increasing the risks for:
- Bone fractures,
- Broken bones,
- Osteopenia, and
2.2. Kidney damage and renal failure
Because Truvada was designed to be taken in such high doses for such a long time, and because it is up to the kidneys to expel the drugs from a patient's system, Truvada also puts a lot of stress on the kidneys, as well. This strain can lead to kidney damage and even kidney failure, which can create numerous other medical problems, including lactic acidosis.
2.3. Lactic acidosis
One of the most serious complications that can be created by the kidney problems caused by prolonged use of Truvada is lactic acidosis, or the accumulation of lactate in the bloodstream. Without the kidneys working at full function, they fail to remove enough lactate acid from the blood, creating the following symptoms:
- Vomiting, and
- Difficulties breathing.
Worse, the buildup of lactate acid can alter the pH levels in the bloodstream, creating numerous medical complications. In many cases, these complications can be fatal, especially if a prompt and correct diagnosis is not made and the underlying condition treated.
3. Lawsuits over Truvada's side effects
Numerous personal injury and TDF HIV Drug lawsuits have been filed against Gilead Sciences, Inc. for their failure to warn patients about the serious side effects of the drug,6 including a class action lawsuit representing victims in the state of California.7 These lawsuits also include allegations that Gilead Sciences, Inc. had developed a drug that was safer than Truvada, but kept it out of production until Truvada's patent was set to expire.
The lawsuits have been filed by a nonprofit organization in Los Angeles, the AIDS Healthcare Foundation, and on behalf of those who have taken Truvada. The claims seek compensation for the medical expenses and other losses associated with a decrease in bone density or kidney damage linked to Truvada.
3.1. Failure to warn claims
The bulk of these lawsuits deal with the claim that Gilead Sciences, Inc. knew that Truvada carried serious risks for severe side effects, but failed to warn doctors or patients of those risks.
Drug manufacturers have a legal duty to warn others about the dangers associated with taking their drugs. These disclosures are meant to allow patients to make informed medical decisions, and to help doctors make better recommendations for their patients. Of course, drug companies have found that disclosing the adverse affects of their drugs can deter potential consumers and hurt their bottom line. Therefore, drug companies frequently use whatever means they can to avoid making these important disclosures.
The lawsuits claim that Gilead knew that the drug TDF was very toxic in the prescribed doses, and even sought a safer version of it right after TDF was approved by the FDA in 2001.8 Nevertheless, Gilead continued to tout TDF and Truvada as “risk-free,” even after the FDA reprimanded them in 2002 and 2003 for false claims that TDF did not put a patient's bone density or kidneys in jeopardy.9 Truvada continued to be marketed as a non-toxic drug that did not imperil a patient's bone density or kidneys, in spite of a growing body of scientific evidence to the contrary.10
3.2. Claims that Gilead withheld a safer drug
A significant portion of the failure to warn claim in these lawsuits deals with Truvada manufacturer Gilead's concealed development of another drug, tenofovir alafenamide, or TAF.
An alternative to TDF, the main ingredient in Truvada and other pill treatments for HIV/AIDS, TAF is more easily absorbed in the body and so was effective in drastically lower doses. Gilead had been investigating TAF even before Truvada was approved in 2004.11 Those studies revealed not only that TAF was far less toxic, but also that TDF carried serious risks.12
However, TDF and Truvada had only recently been patented, and still had years of protection against generic brands. TDF was also the dominant drug in HIV treatment, which allowed Gilead to charge extremely high prices per dose.13
Therefore, rather than release the studies that found TAF was a less toxic alternative to TDF, Gilead covered them up, instead.14 In 2004, Gilead even announced that it would stop researching TAF – and then promptly applied for and received seven patents related to TAF in the span of the next several months.15
Finally, in 2010, with the patent on TDF and Truvada running out, Gilead announced the discovery of a new drug that would revolutionize HIV treatment – TAF.16 Gilead began unveiling the results of its studies on TAF, which had been done years earlier, as proof that it was a better drug for HIV treatment; one with fewer risks of bone density problems and kidney damage than TDF.17 Gilead urged patients on Truvada and pills based on TDF to switch to newer, TAF-based drugs like:
- Odefsey, and
The lawsuits against Gilead claim that not only did the concealed development of TAF strongly indicate that Gilead knew that TDF carried significant risks, it also seriously hurt everyone taking Truvada and other TDF-based HIV treatments. For nearly a decade, they were put at severe risk of osteoporosis, bone fractures, kidney damage, renal failure, and potentially fatal lactic acidosis because Gilead wanted to pad their bottom line by withholding a better treatment until the patent on their existing drug ran out.
4. Compensation available for victims of Truvada
Victims of Truvada are likely to have suffered very serious injuries and amassed steep medical bills and other losses. Filing a defective drug lawsuit against Gilead can recover the compensation that victims deserve for the losses, pain, and suffering that they have sustained through no fault of their own.
These compensatory damages can come in a variety of forms, including:
- The costs of medical expenses incurred, and that are likely to be incurred in the future, for the medical conditions caused by Truvada,
- Professional repercussions, like lost wages and a reduced earning capacity, caused by those medical conditions,
- Physical pain and mental suffering and anguish, and
- The loss of consortium suffered by a victim's family.
Additionally, lawsuits pending against Gilead for the effects of Truvada have sought punitive damages.19 These damages seek to punish the makers of defectively advertised drugs for their egregious and dangerous conduct.
5. What you can do if you have been hurt
If you have been taking Truvada and suspect that you have suffered one of the serious side effects related to it, you should consult a doctor, first. Bone density and kidney tests can detect problems before they become so severe that they can impact or even endanger your life.
If those tests find that you are suffering from the adverse effects of Truvada, you may want to consider talking with a lawyer. Drug companies like Gilead have a legal duty to warn people about the dangers associated with their drugs. When they decide not to, innocent people can get hurt through no fault of their own. Holding those companies accountable for their actions often involves making them pay compensation to the victims.
6. Contact our defective drug lawyers
The defective drug lawyers at the Shouse Law Office represent people who have been hurt by a drug company's wrongdoing. It is important to act quickly, as there is a statute of limitation (deadline) for filing a Truvada lawsuit or claim. Call us at 855-LAWFIRM to schedule a consultation that can start your claim for compensation.
Iwen F Grigsby, Lan Pham, Louis M Mansky, Raj Gopalakrishnan, and Kim C Mansky, “Tenofovir-associated bone density loss,” Therapeutics and Clinical Risk Management 6:41-7 (2010).
Willem D.F. Venter, June Fabian, and Charles Feldman, “An overview of tenofovir and renal disease for the HIV-treating clinician,” South African Journal of HIV Medicine 19(1):817 (2018).
Pablo Rivas, Jorge Polo, Miguel de Górgolas, Manuel L Fernández Guerrero, “Drug points: Fatal lactic acidosis associated with tenofovir,” British Medical Journal 327:711 (2003).
Complaint at 1, Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).
Id. at 2.
Id. at 2-4.
Id. at 3.
The yearly cost of Truvada was $18,456 (Id. at 5).
Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018).
See Id. and Complaint at 4.
Petersen, supra note 14.
Complaint at 17, Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018).